UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010600 |
|---|---|
| Receipt number | R000012391 |
| Scientific Title | The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients |
| Date of disclosure of the study information | 2013/04/26 |
| Last modified on | 2013/04/26 14:07:16 |
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Basic information
Public title
The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients
Acronym
The VSSPS (Vasodilation vs Sympatholytic antihypertensives on Sleep blood Pressure in hypertensive patients with Sleep apnea syndrome) study.
Scientific Title
The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients
Scientific Title:Acronym
The VSSPS (Vasodilation vs Sympatholytic antihypertensives on Sleep blood Pressure in hypertensive patients with Sleep apnea syndrome) study.
Region
| Japan |
Condition
Condition
hypertension with obstructive sleep apnea syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The patients with obstructive sleep apnea syndrome (OSAS) occurs micro-arousal induced apnea during sleep, which lead to sympathetic nervous activation. The blood pressure (BP) surge during sleep in the patients with OSAS might be caused by sympathetic nervous activation. The aim of this study is to compare the effect of carvedilol that have the inhibition of both alfa and beta sympatholytic action with nifedipine on BP surge during sleep in the patients with OSAS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the inhibition of BP surge during sleep between two groups.
Key secondary outcomes
Maximum, minimum and average BP during sleep, morning BP, AHI
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carvedilol 10-20mg one time dose, followed by Nifedipine 20-40mg one time dose after the 2weeks washout period.
Interventions/Control_2
Nifedipine 20-40mg one time dose, followed by Carvedilol 10-20mg one time dose after the 2weeks washout period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertensive subjects with OSAS (AHI>15/hr) 1) who were diagnosed previously by the polysomnography, 2) who were unwilling to receive continuous positive airway pressure (CPAP), and whose sleep BP (measured by ABPM) >120/70 mmHg, were recruited.
Key exclusion criteria
Exclusion criteria as follows
1) The patients treated with anti-sympathetic nervous activation agents
2) The patients with bedtime dosing of antihypertensive drug
3) The patients with congestive heart failure (more than NYHA II)
4) The patients with malignancy
5) The patients with renal failure (serum creatinine >2.0 mg/dL) or performing hemodialysis or severe liver dysfunction
6) The patients with contraindication of these drugs
7) The patients with past history of serious side effects
8) The patients who is not given informed consent by themselves
9) The patients decided inappropriate subjects for this study by physicians
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
+81-285-58-7538
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鷲谷病院 Washiya hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 26 | Day |
Last modified on
| 2013 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012391
